This role is ideal for a regulatory professional with strong experience in FDA, Health Canada, and EU medical device requirements. The Regulatory Affairs Specialist will maintain global registrations and technical documentation, support audits, manage product compliance throughout the lifecycle, and provide strategic regulatory input to cross-functional teams.
Maintain and update European technical files, including risk assessments, usability reports, and clinical evaluations
Prepare and execute annual regulatory registrations for the U.S. (FDA), Canada, and other global markets
Assist international distributors with product registration and compliance requirements
Review product changes to ensure ongoing regulatory conformity
Evaluate product labeling, marketing content, and advertising materials for compliance
Support and manage product recalls, adverse event reporting (MDR/Vigilance), and regulatory communications
Lead and support regulatory audits and inspections by the FDA, Notified Bodies, and customers
Prepare change notifications for submission to global regulatory authorities
Draft, revise, and maintain SOPs related to regulatory processes
Maintain regulatory certificates including the Certificate to Foreign Government (CFG)
Respond to customer surveys, internal requests, and other ad hoc regulatory needs
Collaborate with Quality, R&D, and Manufacturing to maintain compliance across the product lifecycle
Other duties as assigned
Bachelor's degree in a scientific, technical, or regulatory discipline
Minimum 3 years' experience in Regulatory Affairs within an FDA-registered and ISO-certified medical device company
Hands-on experience with:
Technical files and global registrations
Medical Device Reporting (MDR)
Vigilance and recall management
Change control and agency notifications
Working knowledge of:
FDA 21 CFR Part 820
ISO 13485
Health Canada and European medical device regulations (including MDR)
ISO 14971 and MDSAP
Strong organizational and time-management skills with keen attention to detail
Clear and professional written and verbal communication skills
Able to work independently and take ownership of assigned responsibilities
Familiarity with sterilization processes (EO and Gamma) is strongly preferred
Proficiency with Microsoft Office Suite